Non-Invasive Follow-Up of Patients With Coronary Artery Disease Treated With Drug-Coated Balloon PCI Using CT-Derived Fractional Flow Reserve

Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons Computed-Tomography Fractional Flow Reserve Sub-Study

This study investigates changes in coronary artery anatomy and physiology after treatment with a paclitaxel drug-coated balloon (DCB) during percutaneous coronary intervention (PCI). Unlike conventional stenting, DCB treatment delivers an antiproliferative drug to the vessel wall without leaving a permanent metallic implant. The absence of a permanent implant allows non-invasive assessment of the treated coronary artery during follow-up using coronary CT angiography (CCTA).

Participants will undergo two CCTA examinations: an early scan within two weeks after PCI and a follow-up scan after nine months. CT-derived fractional flow reserve (CT-μFR) will be calculated from both scans to assess changes in μFR of the treated coronary artery over time. CCTA will also be used to evaluate changes in coronary plaque and vessel characteristics.

The primary objective is to determine whether CT-μFR changes between early and nine-month follow-up after DCB-PCI. Secondary objectives include evaluating changes in plaque and vessel characteristics on CCTA and assessing clinical outcomes during follow-up.

Inclusion Criteria:

• Age ≥ 18 years;
• Presence of a de novo lesion;
• Successful DCB-PCI of a native coronary artery or major side branch.

Exclusion Criteria:

• No Protégé DCB was used;

• Previous CABG;

• Ineligibility for CCTA acquisition due to:

  • Known renal insufficiency, i.e. eGFR ≤ 30 mL/min/1.73m²;
  • Known hypersensitivity or contraindication to CT contrast agents;
  • Body weight > 150 kg.

• Metallic implants in or around the target vessel;

• Pregnancy or pregnancy status unknown;

• Presence of a comorbid condition with a life expectancy of less than one year;

• Inability to provide informed consent